Death, Sudden, CardiacPREVENTIONACHDNCT03957824
PREVENTION-ACHD Risk Score
An observational study of Death, Sudden, Cardiac and Ventricular Fibrillation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Sudden, Cardiac, Ventricular Fibrillation, Ventricular Tachycardia
- What is being tested?
- PREVENTION-ACHD risk score
- How many people
- 783 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with congenital heart disease with a diagnosis of one of the congenital heart defects displayed in the risk score model.
Who may be able to join
- adult (≥18 years old) patient with a diagnosis of a congenital heart defect.
Who cannot join
- Patients of whom follow up is not possible, e.g. no permanent home address, living outside of or expecting to move out of the area wherein travelling to the investigating hospital outpatient clinic is possible.
- Patients with documented sustained ventricular tachycardia or ventricular fibrillation.
- Patients for whom the risk is not calculable because of a congenital heart disease diagnose not represented in the risk score.
- Patients for whom the risk score is not calculable because of missing data
- Patients with recent (<3 months ago) myocardial infarction.
- Patients in whom the high SCD-risk status depends on an impaired ejection fraction that is expected to improve, e.g. due to tachycardiomyopathy.
- Patients with a guideline defined contraindication for ICD implantation.
About this study
Official title: PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects
Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young patient population. The reason for this is the fact that this is a heterogenous group of patients and SCD is a relatively rare event. Because of this there have been no prospective studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD have shown that this treatment does appear to be effective. Researchers from the Academic Medical Center have identified several risk factors for sudden cardiac death. A risk score was created using this data, which has been validated in an internal and external cohort in a retrospective setting. The design of this study, including the conception of the risk score, its calculation method and validation will be published in an international scientific peer-reviewed journal.
The hypothesis of this study is that the risk score accurately predicts the risk of sudden cardiac death.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Ventricular Tachycardia, Congenital Heart Disease
- Being tested
- PREVENTION-ACHD risk score
- Keywords
- Risk score, Risk prediction, Prevention
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Ventricular, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENTION-ACHD risk scoreDiagnostic test
The predicted risk of sudden cardiac death according to a risk score will be tested by the actual rate of sudden cardiac death
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia
The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients
Measured: 2 years
Secondary outcomes (1)
Sudden cardiac death
The rate of sudden cardiac death in adult congenital heart disease patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2015
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 783 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joris R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Joris R de Groot, MD, PhD, Principal investigator, Academic Medical Center - University of Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957824
- Sponsor's protocol ID
- 2014_248#C20141535
- Acronym
- PREVENTIONACHD
- Status last verified
- May 2019
- First submitted
- 19 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vehmeijer JT, Koyak Z, Zwinderman AH, Harris L, Peinado R, Oechslin EN, Silversides CK, Bouma BJ, Budts W, van Gelder IC, Oliver JM, Mulder BJM, de Groot JR. PREVENTION-ACHD: PRospEctiVE study on implaNTable cardioverter-defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease; Rationale and Design. Neth Heart J. 2019 Oct;27(10):474-479. doi: 10.1007/s12471-019-1297-3.
PubMed 31270738
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT03957824
- Acronym / sponsor ID
- PREVENTIONACHD / 2014_248#C20141535
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Ventricular Tachycardia, Congenital Heart Disease
- Keywords
- Risk score, Risk prediction, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young patient population. The reason for this is the fact that this is a heterogenous group of patients and SCD is a relatively rare event. Because of this there have been no prospective studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD have shown that this treatment does appear to be effective. Researchers from the Academic Medical Center have identified several risk factors for sudden cardiac death. A risk score was created using this data, which has been validated in an internal and external cohort in a retrospective setting. The design of this study, including the conception of the risk score, its calculation method and validation will be published in an international scientific peer-reviewed journal.
The hypothesis of this study is that the risk score accurately predicts the risk of sudden cardiac death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with congenital heart disease with a diagnosis of one of the congenital heart defects displayed in the risk score model.
Key inclusion criteria (1 listed)
- adult (≥18 years old) patient with a diagnosis of a congenital heart defect.
Key exclusion criteria (7 listed)
- Patients of whom follow up is not possible, e.g. no permanent home address, living outside of or expecting to move out of the area wherein travelling to the investigating hospital outpatient clinic is possible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVENTION-ACHD risk scoreThe predicted risk of sudden cardiac death according to a risk score will be tested by the actual rate of sudden cardiac death | Diagnostic test | – |
Primary outcome
Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia
Time frame: 2 years
The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients
1 secondary outcome
Sudden cardiac death
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 31270738Vehmeijer JT, Koyak Z, Zwinderman AH, Harris L, Peinado R, Oechslin EN, Silversides CK, Bouma BJ, Budts W, van Gelder IC, Oliver JM, Mulder BJM, de Groot JR. PREVENTION-ACHD: PRospEctiVE study on implaNTable cardioverter-defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease; Rationale and Design. Neth Heart J. 2019 Oct;27(10):474-479. doi: 10.1007/s12471-019-1297-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris R de Groot, MD, PhD principal investigator
Academic Medical Center - University of Amsterdam (AMC-UvA)
Questions about this trial
What is this clinical trial studying?
An observational study of Death, Sudden, Cardiac and Ventricular Fibrillation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.